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A Prospective, Single-arm, Exploratory Study of Trifluridine/Tipiracil (TAS-102) Combined With Apatinib as Third-line Therapy for Advanced Gastric Cancer

ConditionAdvanced Gastric Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAnhui Provincial Cancer Hospital

About this trial

To evaluate the efficacy and safety of trifluridine/tipiracil (TAS-102) combined with apatinib as third-line therapy for advanced gastric cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Gastric cancer confirmed by histopathological or cytological diagnosis;

unresectable locally advanced or recurrent/metastatic gastric cancer;

age 18-75 years, regardless of gender;

ECOG score 0-2;

Disqualifiers

Participation in other anti-tumor drug clinical trials within 4 weeks prior to enrollment;

Any of the following conditions that may interfere with oral medication: inability to swallow, chronic diarrhea, or intestinal obstruction;

Concurrent receipt of any other systemic anti-tumor therapy (excluding local treatment);

Previous treatment with VEGFR inhibitors (excluding ramucirumab; pan-targeted TKIs are excluded);

Trial design

Design model

Single group

Treatments tested in this trial

  • Trifluridine/Tipiracil (TAS-102) combined with Apatinib

    Drug

    TAS-102: 35 mg/m2/dose, taken orally within 1 hour after breakfast and dinner, twice daily, on days 1-5 of each cycle, followed by a 9-day drug-free interval, with 28 days constituting one cycle. Apatinib: 500 mg/dose, once daily, administered continuously for 5 days followed by a 2-day break, with 28 days as one cycle. Imaging evaluation should be performed every 2-3 cycles until disease progression or intolerance occurs.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: research groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate，ORR

Time frame
Perform imaging evaluation At the end of Cycle 2 or Cycle3 (each cycle is 28 days).

Secondary outcomes

1

Duration of Response，DOR

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
2

Progression-Free Survival，PFS

Time frame
From date of first dose administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anhui Provincial Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: